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marthambles

09/22/11 12:51 PM

#5944 RE: GrthzGd #5943

GrthzGd

Very clever theory. A significant pillar of this theory would have to be knowledge on the part of A/W that they are, in fact, violating MNTA's patent. A/W is the only one who knows their formulation and the various processes that were necessary to perform in order to obtain FDA approval. Accordingly, they already know, if not the outcome of the litigation, at least whether or not MNTA has a strong case.
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linhdtu

09/22/11 1:06 PM

#5945 RE: GrthzGd #5943

GrthzGd, thank you for the long explanation.

However if AW launch in Q42011 as in the PR, then wouldn't that invalidate your conjecture ?

Isn't the key to whole mystery of AW a-enox approval is that whether Amphastar can reproduce Lovenox without somehow using Mnta IP ?

And like you say, only they know the answer to that. We don't know that and to some degree MNTA does not know that .

The same logic applies to m-copax. The FDA can/will grant approval to m-copax once they are satisfied with whatever make them happy. Whether MNTA lose their shirt in court or not does not concern them, nor does that legal consideration should enter into their decision to approve or not approve.
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HattieTheWitch

09/22/11 1:32 PM

#5947 RE: GrthzGd #5943

"GrthzGd hypothesis."--Full Exposition...

Thank you. That makes a lot of sense.